AZD6765 Oral Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)

NCT00963365 | Withdrawn Phase 1

• 1 other identifier: D6703C00001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.

Conditions

Healthy

Keywords

Phase 1; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG).

  Safety assessments are made prior to and after drug administration.

Secondary Outcomes (2)

• Part A 1. To characterize the single dose pharmacokinetics of AZD67652. To assess the absolute bioavailability of AZD67653. To assess the effect of food on the pharmacokinetics of AZD6765

  Blood samples will be obtained on Days 1-5.

• Part B 1. To characterize the single and multiple dose pharmacokinetics of AZD6765 2. To assess dose linearity and proportionality of AZD67653. To assess the degree of accumulation and the time dependence of the pharmacokinetics of AZD6765

  Blood samples will be obtained on Days 1-4 and 7-11.

Study Arms (4)

AZD6765 oral solution

EXPERIMENTAL

Active

Drug: AZD6765

AZD6765 IV infusion

EXPERIMENTAL

Active

Drug: AZD6765

Placebo to AZD6765 oral solution

PLACEBO COMPARATOR

Placebo

Drug: AZD6765

Placebo to AZD6765 IV infusion

PLACEBO COMPARATOR

Placebo

Drug: AZD6765

Interventions

AZD6765 DRUG

Single oral dose and single IV infusion of AZD6765

AZD6765 IV infusion; AZD6765 oral solution; Placebo to AZD6765 IV infusion; Placebo to AZD6765 oral solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Females must be of non-childbearing potential.

You may not qualify if:

• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months (if half-life was \< 24 hours) of the first administration of study drug
• Plasma or blood product donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

AZD6765

Study Officials

• Phillip Leese, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2010
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

US (1)